{"id":8361,"date":"2021-09-21T09:45:04","date_gmt":"2021-09-21T07:45:04","guid":{"rendered":"https:\/\/www.medicoforum.com\/clinical-evaluation\/"},"modified":"2024-05-17T18:28:50","modified_gmt":"2024-05-17T16:28:50","slug":"clinical-evaluation","status":"publish","type":"page","link":"https:\/\/www.medicoforum.com\/en\/clinical-evaluation\/","title":{"rendered":"Clinical evaluation"},"content":{"rendered":"\n<style type=\"text\/css\" data-created_by=\"avia_inline_auto\" id=\"style-css-av-bd796f-d0fb62a1ca4db618da335498cbc17266\">\n.avia-section.av-bd796f-d0fb62a1ca4db618da335498cbc17266{\nbackground-repeat:no-repeat;\nbackground-image:url(https:\/\/www.medicoforum.com\/wp-content\/uploads\/2020\/03\/layerformat_medicoforum_about_02.jpg);\nbackground-position:50% 0%;\nbackground-attachment:fixed;\nmargin-top:0px;\nmargin-bottom:60px;\n}\n.avia-section.av-bd796f-d0fb62a1ca4db618da335498cbc17266 .av-section-color-overlay{\nopacity:0.9;\n}\n#top 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clearfix'>\n<div  class='flex_column av-9ew7w7-dc837895b7f19a8b868c8a2bb10e614d av_one_third  avia-builder-el-1  el_before_av_two_third  avia-builder-el-first  first flex_column_div  '     ><\/div>\n<style type=\"text\/css\" data-created_by=\"avia_inline_auto\" id=\"style-css-av-8tldev-7477fe854a43569da6a34da5169a9b8c\">\n.flex_column.av-8tldev-7477fe854a43569da6a34da5169a9b8c{\nborder-radius:0 21px 21px 21px;\npadding:34px 34px 34px 34px;\n}\n<\/style>\n<div  class='flex_column av-8tldev-7477fe854a43569da6a34da5169a9b8c av_two_third  avia-builder-el-2  el_after_av_one_third  avia-builder-el-last  whiteleft flex_column_div  '     ><section  class='av_textblock_section av-ldt3y17x-8993d3bfb7c3c742d3d319ba8ae5ab83 '   itemscope=\"itemscope\" itemtype=\"https:\/\/schema.org\/CreativeWork\" ><div class='avia_textblock'  itemprop=\"text\" ><h1><span class=\"clbold\">Clinical evaluation: <\/span>assess safety, performance and benefits.<\/h1>\n<\/div><\/section><br \/>\n\n<style type=\"text\/css\" data-created_by=\"avia_inline_auto\" id=\"style-css-av-4wb7k7-6e210fbbd59127907a22efbb79467c19\">\n#top .hr.av-4wb7k7-6e210fbbd59127907a22efbb79467c19{\nmargin-top:10px;\nmargin-bottom:10px;\n}\n.hr.av-4wb7k7-6e210fbbd59127907a22efbb79467c19 .hr-inner{\nwidth:50px;\nborder-color:#000000;\n}\n<\/style>\n<div  class='hr av-4wb7k7-6e210fbbd59127907a22efbb79467c19 hr-custom  avia-builder-el-4  el_after_av_textblock  el_before_av_button  hr-left hr-icon-no'><span class='hr-inner inner-border-av-border-fat'><span class=\"hr-inner-style\"><\/span><\/span><\/div><br \/>\n<div  class='avia-button-wrap av-ld91m096-0815fddfa9d68fce07ee5ef111dee066-wrap avia-button-center  avia-builder-el-5  el_after_av_hr  el_before_av_hr  diamond'>\n<style type=\"text\/css\" data-created_by=\"avia_inline_auto\" id=\"style-css-av-ld91m096-0815fddfa9d68fce07ee5ef111dee066\">\n#top #wrap_all .avia-button.av-ld91m096-0815fddfa9d68fce07ee5ef111dee066{\nbackground-color:#edf5f9;\nborder-color:#edf5f9;\ncolor:#666666;\ntransition:all 0.4s ease-in-out;\n}\n#top #wrap_all .avia-button.av-ld91m096-0815fddfa9d68fce07ee5ef111dee066 .avia-svg-icon svg:first-child{\nfill:#666666;\nstroke:#666666;\n}\n<\/style>\n<a href='#contactform'  class='avia-button av-ld91m096-0815fddfa9d68fce07ee5ef111dee066 av-link-btn avia-icon_select-yes-left-icon avia-size-x-large avia-position-center'   aria-label=\"Get in touch now\"><span class='avia_button_icon avia_button_icon_left avia-iconfont avia-font-medicoforum_icon' data-av_icon='\ue900' data-av_iconfont='medicoforum_icon' ><\/span><span class='avia_iconbox_title' >Get in touch now<\/span><\/a><\/div><br \/>\n\n<style type=\"text\/css\" data-created_by=\"avia_inline_auto\" id=\"style-css-av-ldukjjs5-f6249d5bb4e898ea3b0b82767254a852\">\n#top .hr.av-ldukjjs5-f6249d5bb4e898ea3b0b82767254a852{\nmargin-top:10px;\nmargin-bottom:10px;\n}\n.hr.av-ldukjjs5-f6249d5bb4e898ea3b0b82767254a852 .hr-inner{\nwidth:50px;\nborder-color:#000000;\n}\n<\/style>\n<div  class='hr av-ldukjjs5-f6249d5bb4e898ea3b0b82767254a852 hr-custom  avia-builder-el-6  el_after_av_button  el_before_av_textblock  hr-left hr-icon-no'><span class='hr-inner inner-border-av-border-none'><span class=\"hr-inner-style\"><\/span><\/span><\/div><br \/>\n<section  class='av_textblock_section av-k7ooakmw-613eaad5cb9fbc26042fa1e57faaf447 '   itemscope=\"itemscope\" itemtype=\"https:\/\/schema.org\/CreativeWork\" ><div class='avia_textblock strongblack'  itemprop=\"text\" ><h3>Clinical evaluation is an important building block on the way to MDR certification<\/h3>\n<p>Clinical evaluation is indispensable to assess and ensure the safety, performance and benefits of a medical device. For this purpose, data is systematically generated, collected, analyzed and evaluated accordingly. On the basis of these results, the manufacturer of the medical device can assess whether the potential risks of use are in reasonable proportion to the predicted benefits.<\/p>\n<p>Clinical evaluation is thus an important part of the documentation, quality management and risk management of a medical device. Regulations such as the Medical Device Regulation (MDR) place high demands on the documentation and manufacturers of medical devices. As part of this documentation, the clinical evaluation is required to successfully complete the European conformity assessment procedure for medical devices and to obtain the CE marking.<\/p>\n<h2>What criteria must the clinical evaluation meet<\/h2>\n<p>During the clinical evaluation, clinical data are collected from different sources, such as published clinical trials or studies conducted with similar approved products (equivalence principle).<\/p>\n<h3>Clinical evaluation format<\/h3>\n<p>The <a href=\"https:\/\/www.medicoforum.com\/wp-content\/uploads\/meddev-2-7-1-rev4.pdf\" target=\"_blank\" rel=\"nofollow noopener\">guideline MEDDEV 2.7\/1<\/a> of the European Commission is decisive for the format of the clinical evaluation.<\/p>\n<h3>Continuous acquisition<\/h3>\n<p>Clinical evaluation is a continuous and systematic process that begins before MDR certification is obtained and includes clinical follow-up after a product is launched on the market, in accordance with the legally mandated European Medical Device Regulation (MDR) 2017\/745.<\/p>\n<p>According to the MDR, possible acceptance criteria and milestones should already be described during the planning of clinical trials. Step-by-step planning and a cautious approach are intended to minimize unknown risks, especially with new products and processes.<\/p>\n<h3>Continuous assessment<\/h3>\n<p>The result of the clinical evaluation is the Clinical Evaluation Report (CER), which is kept up to date by constant observation and evaluation of available data for the medical device. This allows unidentified post-marketing risks to be identified and re-evaluated.<\/p>\n<p>The manufacturer can use current data to weight the justifiability of risks and any side effects that may occur, evaluate long-term safety, efficacy and interactions with other products. Waiver of clinical data is possible only in exceptional cases, and clinical evaluation is mandatory even in these cases.<\/p>\n<h3>How Medicoforum supports you<\/h3>\n<p><strong>Contact us if you need advice or support in preparing your clinical evaluation under MDR or associated components of your medical device documentation. We can support and advise you with our expertise!<\/strong><\/p>\n<\/div><\/section><br \/>\n\n<style type=\"text\/css\" data-created_by=\"avia_inline_auto\" id=\"style-css-av-kttrsoeq-f90a0d34935209dbb6c6aff98f9c0005\">\n#top .hr.hr-invisible.av-kttrsoeq-f90a0d34935209dbb6c6aff98f9c0005{\nheight:25px;\n}\n<\/style>\n<div  class='hr av-kttrsoeq-f90a0d34935209dbb6c6aff98f9c0005 hr-invisible  avia-builder-el-8  el_after_av_textblock  avia-builder-el-last '><span class='hr-inner '><span class=\"hr-inner-style\"><\/span><\/span><\/div><\/p><\/div>[av_section min_height='percent' min_height_pc='77' min_height_px='500px' shadow='no-border-styling' bottom_border='border-extra-arrow-down' bottom_border_diagonal_color='#333333' bottom_border_diagonal_direction='' bottom_border_style='' padding='large' margin='aviaTBmargin' custom_margin='0px,60px' av-desktop-custom_margin='' av-desktop-custom_margin_sync='true' av-medium-custom_margin='' av-medium-custom_margin_sync='true' 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admin_preview_bg='']\n\n[av_textblock fold_type='' fold_height='' fold_more='Weiterlesen' fold_less='Read less' fold_text_style='' fold_btn_align='' textblock_styling_align='' textblock_styling='' textblock_styling_gap='' textblock_styling_mobile='' size='' av-desktop-font-size='' av-medium-font-size='' av-small-font-size='' av-mini-font-size='' font_color='' color='' fold_overlay_color='' fold_text_color='' fold_btn_color='theme-color' fold_btn_bg_color='' fold_btn_font_color='' size-btn-text='' av-desktop-font-size-btn-text='' av-medium-font-size-btn-text='' av-small-font-size-btn-text='' av-mini-font-size-btn-text='' fold_timer='' z_index_fold='' id='' custom_class='' template_class='' av_uid='av-ks0k1swi' sc_version='1.0' admin_preview_bg='']\n<span class=\"clbold\">Our focus:<\/span> MDR consulting and services for medical devices such as quality management, risk management, clinical data and studies or clinical evaluation. <span class=\"clbold\">Project overview:<\/span> 45+ medical device projects (from idea to product) 120+ dossiers 20+ patents <span class=\"clbold\">Competence status<\/span> Certified according to DIN EN ISO 13485:2016, Medical Device Regulation (MDR), Medical Device Law Implementation Act (MPDG), expert knowledge in GCP and GMP as well as ISO 14155 and always up-to-date specialist knowledge. <span class=\"clbold\">About the company:<\/span> Founded in 2003 10+ in-house specialists a large number of satisfied customers <span class=\"clbold\">Project partners:<\/span> Mediconomics GmbH (Europe\/USA\/Canada) DNV MedCert GmbH (Germany)\n[\/av_textblock]\n\n[\/av_one_half][av_one_half min_height='' vertical_alignment='av-align-top' space='' row_boxshadow_width='10' row_boxshadow_color='' margin='0px' margin_sync='true' av-desktop-margin='' av-desktop-margin_sync='true' av-medium-margin='' av-medium-margin_sync='true' av-small-margin='' av-small-margin_sync='true' av-mini-margin='' av-mini-margin_sync='true' mobile_breaking='' 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